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The TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The TUNA® System consists of the TUNA® 3 Catheter, the VIDAMED Model 7205 RF Generator, the VIDAMED Return Electrode, the VIDAMED Rectal Monitoring Tape, and the TUNA® Optics.

The electrosurgical generator is capable of delivering up to 30W (15W / channel) of power and is designed for use with VIDAMED accessory electrodes including the TUNA® 3 Catheter. When used with VIDAMED accessory electrodes, the electrosurgical generator is capable of reading temperature from thermocouple sensors within the electrode and controlling power output to the tissue.

The provided text is a 510(k) summary for the VIDAMED TUNA® (Trans Urethral Needle Ablation) System, which is a medical device for treating benign prostatic hyperplasia (BPH). This document describes the device, its indication, and its substantial equivalence to other devices.

However, it does not contain any information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies related to device performance.

The summary states: "Confirmatory clinical data is also provided to support the safety and effectiveness of the device for use in the treatment of symptoms due to urinary outflow obstruction secondary to BPH." However, it does not detail the specifics of this clinical data or how it relates to acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information as the input text does not contain it.

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